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Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients

Phase 1/2A Study of Rintatolimod and IFN Alpha Regimen in Cancer Patients With COVID-19

NCT04379518•Roswell Park Cancer Institute

Summary

This phase I/IIa trial studies the best dose and side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the safety of the combination of intravenous (i.v.) rintatolimod administered with or without i.v. IFN alpha (recombinant interferon alfa-2b \[Intron A\]) in patients with cancer with coronavirus disease 2019 (COVID-19). II. Determine the kinetics of viral load in nasopharyngeal swabs in the course of treatment and Days 7 and 14. SECONDARY OBJECTIVES: I. To assess the efficacy of the treatment combination in patients with cancer with COVID-19. II. Determine the kinetics of viral load in the peripheral blood in the course of treatment and Days 7 and 14. III. Determine the kinetics of changes of the immune subsets and circulating inflammatory mediators (including C-reactive protein \[CRP\], cytokines, chemokines, interferons) in peripheral blood in the course of treatment and Days 7 and 14. IV. Determine the induction of known mediators of antiviral immunity that include (myxovirus resistance gene, MxA; protein Kinase R (PKR); oligoadenylate synthetase-2 (OAS2); RNAse-L, IFN-stimulated gene-15 (ISG15); IFN-induced proteins with tetratricopeptide repeats (IFIT1) and IFN-inducible transmembrane protein 3 (IFITM3), TLR3, RIG-I, MDA5, IRF3, IRF7, in nasopharyngeal swabs material and blood cells of patients on all tiers of treatment. OUTLINE: This is a phase I, dose-escalation study of recombinant interferon alfa-2b followed by a phase II study. LEAD-IN PHASE: Patients receive rintatolimod IV over 2.5-3 hours on day 1 and day 3 (or 4). ARM I: Patients receive rintatolimod IV over 2.5-3 hours and recombinant interferon alfa-2b IV over 20 minutes on day 1 and on day 3 or 4 in the absence of disease progression or unacceptable toxicity. EXPANSION COHORT: ARM III: Patients receive rintatolimod IV over 2.5-3 hours along with standard of care. Patients are followed up at days 7, 14 and 30 after initiation of the study regimen.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with cancer, with the exception of patients with active acute leukemia and allogeneic hematopoietic stem cell transplant recipients. Patients may be on active therapy or received therapy (e.g., chemotherapy, radiation or surgery) within 7 years. Patients with active cancer who have not yet been treated (e.g. newly diagnosed cancer or early stage myelodysplastic syndrome \[MDS\] or chronic lymphocytic leukemia \[CLL\]) are eligible. Basal cell cancer and carcinoma in situ treated with local excision alone do not qualify for inclusion
•Presence of symptomatic infection, defined by fever (temperature \[T\] \>= 38 degrees Celsius \[C\]) OR respiratory symptoms (cough, nasal congestion, or shortness of breath) OR lung infilitrates on chest X-ray or CT imaging. Diagnosis of COVID-19 is based on polymerase chain reaction (PCR) testing of respiratory samples.
•Age equal to \>= 18 years or older (children are excluded because COVID-19 typically has a milder course in children, and lack of safety data of this regimen in children)
•Platelet \>= 75,000/uL
•Hemoglobin \>= 9 g/dL
•Hematocrit \>= 27%
•Absolute neutrophil count (ANC) \>= 1000/uL
•Creatinine clearance \>= 50 mL/min (Cockcroft-Gault Equation-note: plasma creatine instead of serum is used at Roswell Park)
•Total bilirubin =\< 2 X institutional upper limit of normal (ULN)
•Aspartate transaminase (AST) (plasma) and alanine transferase (ALT) (plasma) =\< 2 X institutional ULN
+11 more criteria

Exclusion Criteria

•Patients with severe COVID-19 infection defined by pulmonary infiltrates on chest x-ray or computed tomography (CT) imaging plus one of the following: room air oxygen saturation (SaO2) =\< 92%, room air partial pressure of oxygen (PaO2) \< 70 mm Hg, or partial pressure of oxygen in arterial blood (PaO2)-PaO2 (alveolar gas) \>= 35 mm Hg
•Contraindication to recombinant (r)-INFalpha based on prior hypersensitivity, autoimmune hepatitis, decompensated liver disease
•Cardiac events:
•* Acute coronary syndrome, myocardial infarction, or ischemia within past 3 months
•* New York Heart Association classification of III or IV congestive heart failure
•Unwilling or unable to follow protocol requirements
•Patients with known serious mood disorders
•Any additional condition, such as pre-existing inflammatory lung disease, which in the investigator's opinion deems the participant an unsuitable candidate to receive the study drugs
•Concurrent infections, e.g. bacterial pneumonia or sepsis, that would make it difficult to evaluate clinical response to therapy or study drug toxicities
•Therapies known to cause cytokine release syndrome (CRS), e.g. engineered T cells, within 30 days
+16 more criteria

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Key Dates

Start Date

November 17, 2020

Primary Completion Date

March 15, 2023

Completion Date

March 15, 2023

Last Updated

January 13, 2026

Enrollment

ACTUAL participants

Conditions

Hematopoietic and Lymphoid Cell NeoplasmMalignant Solid NeoplasmSymptomatic COVID-19 Infection Laboratory-Confirmed

Interventions

Recombinant Interferon Alfa-2b

BIOLOGICAL

Rintatolimod

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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